Regulatory Focus™ > News Articles > Pharmaceutical Security, Compounding Reform Bill Could Soon Become Law

Pharmaceutical Security, Compounding Reform Bill Could Soon Become Law

Posted 13 November 2013 | By Alexander Gaffney, RAC

Senate legislators are preparing to pass the Drug Quality and Security Act (DQSA), a long-delayed piece of legislation that would institute a national track and trace system for pharmaceutical products and a series of reforms intended to better regulate compounding pharmacies in the wake of major problems that left dozens dead.


The DQSA was prompted by two issues. The first and perhaps most serious problem has been the lack of a uniform "track and trace" system for pharmaceutical products. While California has moved to implement just such a system (which has in turn become something of a de facto standard for all US companies due to California's market share), legislators have been interested in implementing a national standard to avoid other states introducing competing ones.

The other hope, of course, is that the system will allow regulators to keep better track of the pharmaceutical supply chain, cutting down on counterfeiters and allowing them to respond more quickly to other problems as well.

The second problem, and the subject of numerous congressional hearings, has been the issue of drug compounding. Under federal law, pharmaceutical compounders are treated as separate entities from pharmaceutical manufacturers, and are allowed to operate under state-not federal-oversight. In late 2012, a massive outbreak of fungal meningitis caused by contaminated steroid injections caused legislators to re-evaluate that paradigm.

Lengthy Delays

While the legislation has received generally positive support from legislators, it has been placed on hold several times as several more pressing issues have emerged. In 2012, the track and trace provisions were dropped from the Food and Drug Administration Safety and Innovation Act (FDASIA) after differences emerged and legislators feared that the must-pass legislation could be hijacked for other purposes if it was not passed before the Supreme Court made a decision with respect to the legality of the Affordable Care Act.

The legislative effort then went on to include pharmaceutical compounding provisions as well, but both were put on hold early in 2013 as budget battles occupied the attention of legislators. In April, efforts by the pharmaceutical trade groups PhRMA and GPhA seemed to bring legislators back to the table, and the DQSA eventually saw passage in the House.

But since then, the DQSA has stalled out once again, and again thanks to budget battles that saw the federal government mostly shut down through the first half of October 2013. And as Focus reported on 24 October 2013, that led to another effort by the public health advocacy group Pew Charitable Trusts to get legislators to finally vote on the bill.

Most recently, a vote on the bill was scuttled after Sen. David Vitter said he would not support it without changes to provisions under the Affordable Care Act. 

Senate Approval Imminent

That hurdle appears to have now been cleared, with senators voting 97-1 to advance the measure in a procedural vote (a vote to have a vote) held 12 November.

The bill must still be voted on again, but the overwhelming passage during the procedural session indicates the bill will have little trouble clearing the Senate. The only no vote was from Vitter, according to The Hill.

"This bill is the culmination of more than two years of bipartisan, bicameral work along with pharmacies, distributors, and prescription drug manufacturers," said Sen. Michael Bennet (D-CO), long an advocate for a track and trace system. "It will help us keep the prescription drug supply safe and keep our families healthy."

"The Senate should consider and pass this legislation immediately so we can help prevent another meningitis outbreak like the one that has killed 16 Tennesseans and made so many others so sick," added Sen. Lamar Alexander (R-TN), one of the bill's sponsors and the ranking Republican on the Senate Health, Education, Labor and Pensions (HELP) Committee. "The US Food and Drug Administration (FDA) commissioner has warned us that it's a matter of when, not if, this will happen again if we don't clarify oversight of compounders. Tonight's vote is an important step toward doing just that."

However, in remarks last week, FDA Commissioner Margaret Hamburg told a Bloombergconference that the bill, while better than nothing, was-with respect to compounding-not "as comprehensive as we had hoped."

Assuming passage in the Senate, at its current pace the bill could be signed into law by the end of November 2013.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.